Khalifa Acute Effects | NCT01762371

Studies
Khalifa Acute Effects

NCT01762371

Sponsor

Medical University of Graz

Status

Completed

Last Update Posted

May 5, 2015Estimated

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Totally Ruptured Anterior Cruciate Ligament in the Knee

Interventions

Khalifa Therapy

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Jan 2013Actual

Completion Date

Feb 2014Actual

First Submitted Date

Jan 4, 2013

First Submission Date that Met QC Criteria

Jan 4, 2013

First Posted Date

Jan 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2015

Last Update Posted Date

May 5, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andreas Sandner-Kiesling , MD, Univ.Prof.Dr., Medical University of GrazPrincipal Investigator

Lead Sponsor

Medical University of GrazOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary hypothesis is that Khalifa's therapy has different acute effects in various organ systems i.e. proprioceptive, neuro-muscular, endogenous dopamine system, etc. These effects might indicate the pathway of the therapy.

Detailed Description

According to our previous study that evaluated the efficacy of Khalifa's therapy the investigators have seen that the therapy has acute effects which resulted in better knee function and later even in better healing of the ACL injury. This study should clear exactly which effects and pathways are involved in the therapy from multiple (interdisciplinary) point of views. Therefore the investigators will measure parameters that might be associated with this special technique directly before and after the therapy.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
K-Pat	Experimental	Getting one time one hour of Khalifa's therapy for ACL injury treatment.	Other: Khalifa Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Khalifa Therapy	Other	One hour of Khalifa's therapy which is specially applied pressure to the skin.	K-Pat

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Laser Doppler-Flow	Perfusion	1 hour
NIRS	Near infrared spectroscopy, Oxygen saturation	1 hour
IR Thermography	Infrared thermography, temperature	1 hour
QST	Quantitative sensoric testing, pain	1 hour
HRV	Heart rate variability, sympathicus/parasympathicus activation	1 hour
EEG	Electroencephalogram, brain waves	1 hour
Knee function	IKDC Score KT-1000 test Clinical / physical examination	1 hour
SportsScience	Posturomed Motion capture proprioception muscle power range of motion	2 hours
Blood	Catecholamines endorphins standard blood parameters	1 hour

Secondary Outcomes

Measure	Description	Time Frame
Questionnaire	Different questions about pain, lifestyle, subjective parameters	1 hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

totally ruptured ACL - MRI verified, 2 weeks old as a maximum
knee function: Any functional inhibition (stretching, bending or load)
BMI: 18-25
athletically active

Exclusion Criteria:

any surgical procedures at the injured knee at any previous time
any acute surgical indication
diabetes mellitus and/or high blood pressure
any permanent drug treatment

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andreas Kastner, MD	AKH Linz	Principal Investigator
Andreas Sandner, MD	Med Uni Graz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sports Center of University Salzburg		Hallein	State of Salzburg	5400	Austria